ABSTRACT
Catching up with recent interest in developing green pharmaceutical products, a key challenge is encountering formulation scientists to find proper ingredients, approach or dispense tools in a reasonable time due to manufacturing variability. Therefore, this work aims to demonstrate green, propellent-free, topical pharmaceutical preparation through utilization of the concept of quality by design (QbD) to eliminate or reduce the variability. A foam dosage form with ingredients suitable for potential sunscreen application was developed. Formulation ingredients were based on local Jordanian virgin olive oil. Twenty formulae were screened under the theme of QbD. One formulation successfully combined in relatively stable water in oil emulsion, whereby foam generation was achieved through a specialized dispensing tool. Textural characteristics were evaluated by a human panel (30) and found favourably acceptable for this formulation. Physicochemical characteristics of the investigated and optimized formulae were confirmed through light microscopy, viscosity and spectrophotochemical measurements. Sun protection factor (SPF) was determined as 12.1±0.6 (n=3); indicating potential sunscreen applications for almost two hours in the daytime. Critical quality attributes were determined throughout the development process and risk assessment measurements were estimated thereof. Such an outcome that will help to create preliminary predictive model for scalable industrial screening production of this green pharmaceutical topical preparation with local sourcing of generally regarded safe materials (GRAS).
